Events

Multiple Models of GE Nuclear Medicine Systems:All VG and VG Hawkeye nuclear medicine systems, manufactured from 1996 - 2003: - Millennium VG - Millennium VG and Hawkeye- Discovery VH - VaricamAll Infinia nuclear medicine systems, manufactured from 2003 – 2014:- Infinia - Infinia and Hawkeye - Infinia and Hawkeye 4 All Brivo NM615, Discovery NM630, Optima NM/CT640 and Discovery NM/CT670 systems. 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 GE Healthcare Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2014-RN-01052-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-09-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01052-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Ge healthcare has recently performed field actions (tga ref.: rc-2013-rn-00629-1; rc-2013-rn-00679-1; rc-2013-rn-00695-1) on ge healthcare nuclear medicine system due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry . as part of this field action, ge healthcare is updating the preventative maintenance procedure and schedule and added an additional preventative maintenance check for loose fasteners on the nuclear medicine systems.
  • 조치
    GE Healthcare is advising the customers to ensure that the organization that services the equipment uses the latest version of the Service manual and the Preventative Maintenance procedure available on GE website (link provided in the customer letter)

Device

Multiple Models of GE Nuclear Medicine Systems:All VG and VG Hawkeye nuclear medicine systems, ma...
  • 모델명 / 제조번호(시리얼번호)
    Multiple Models of GE Nuclear Medicine Systems:All VG and VG Hawkeye nuclear medicine systems, manufactured from 1996 - 2003: - Millennium VG - Millennium VG and Hawkeye- Discovery VH - VaricamAll Infinia nuclear medicine systems, manufactured from 2003 – 2014:- Infinia - Infinia and Hawkeye - Infinia and Hawkeye 4 All Brivo NM615, Discovery NM630, Optima NM/CT640 and Discovery NM/CT670 systems.ARTG number: 200439
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd